Hope yes but mind the hype

As 2008 draws to a close, most, if not everyone, will be glad to see the end of 2008 and look forward to a hopefully better 2009 and calmer financial clime. For those of us who treat patients with cancer, every year we always hope for something better to come along for our patients. The recent editorial, by Drs Kelly and Venook of the University of California, in the Journal of Clinical Oncology commented on the recent availability of sorafenib (Nexavar) for the treatment of patients with advanced hepatocellular carcinoma (HCC) and how sorafenib has ‘ushered in an era of hope for patients with HCC’ (J Clin Oncol 2008; 26: 5845 – 5848).

The study showing sorafenib was effective in treating patients with advanced liver cancer was the Sorafenib Hepatocellular Carcinoma Assessment Randomized Protocol (SHARP) study. The data was first reported at the American Society of Clinical Oncology (ASCO) meeting in June 2007. On the basis of these results, the drug was approved in both Europe and the United States a few months later. The SHARP study involved 602 patients, 20% positive for hepatitis B and 30% for hepatitis C. It showed that sorafenib prolonged overall survival to 10.7 months vs 7.9 months on placebo treatment (N Engl J Med 2008; 359: 378 – 390). Corroborating but different results have since been reported from an Asian trial involving 226 patients in which > 70% of them were positive for hepatitis B. The Asian trial showed that patients on sorafenib survived 6.2 months while those on placebo only survived 4.1 months (Lancet Oncol, published online 16/12/2008).

Drs Kelly and Venook wrote “This study (SHARP study) offers the first hope for life prolongation for more than 600,000 patients who die each year from HCC worldwide. With the first hope of an active therapy in a grim disease, there is a natural tendency toward expansiveness – the hype.” They say that clinicians need to question whether the patients who took part in the trial are similar to the patients they see in their office and how far the results can be generalized.

Since sorafenib was made available to all in the second half of 2007, I have, on multiple occasions, encountered patients who refused other forms of treatment and insisted on taking sorafenib alone because they heard or were told that sorafenib is effective against HCC. Unfortunately, the exact role for sorafenib in the management algorithm of HCC has not been defined yet. The data so far tells us that sorafenib, when compared to no treatment at all, can prolong life in patients with advanced HCC and good underlying liver function. It certainly has not been shown to cure patients or prolong life significantly in those with less advanced disease. In the world of finance, if you fall for the ‘hype’ around a bad financial product, you are likely to lose money. If you fall for the ‘hype’ around a new medicine, you are likely to lose more than just money.

Sorafenib has certainly given hope to patients with advanced HCC. Now there are many ongoing studies looking at how to combine sorafenib with other agents in treating other HCC patients. Lets hope these studies will bring better news to our patients in 2009. Happy New Year!